Potactasol (topotecan)
- Region
- 🇪🇺 EU
- Active substance
- topotecan
- Company
- Actavis Group PTC ehf
- Status
- Authorised
- Therapeutic area
- Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
- CHMP opinion
- Thu 21 Oct 2010
- EU approval
- Thu 06 Jan 2011
- Designations
- Generic
- Application
- EMEA/H/C/002282
- ATC
- L01CE01
- Official record
- www.ema.europa.eu
Indication
Topotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy- patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1). Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Topotecan Hospira Authorised · Pfizer Europe MA EEIG
- 🇪🇺 Hycamtin Authorised · Sandoz Pharmaceuticals d.d.
- 🇪🇺 Topotecan Actavis Withdrawn · Actavis Group PTC ehf
- 🇪🇺 Topotecan Teva Withdrawn · Teva B.V.
- 🇪🇺 Topotecan Eagle Withdrawn · Eagle Laboratories Ltd.
- 🇪🇺 Topotecan SUN Application withdrawn · Sun Pharmaceutical Industries Europe B.V.
- 🇪🇺 Evotopin Withdrawn · Beecham Group plc
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